Dermal Patch for Collecting a Physiological Sample

ABSTRACT

A dermal patch for collecting a physiological sample includes a housing with a collection chamber, a sample channel and a pin within a receptacle of the housing. The sample channel is configured to direct a physiological sample drawn from a subject to the collection chamber. The pin is removably positioned within the receptacle and is configured to move from an undeployed position to a deployed position. The pin is configured to seal the receptacle when in the undeployed position and is further configured to facilitate generation of negative pressure in the sample channel when the pin is moved from the undeployed to the deployed position.

RELATED APPLICATIONS

The present application a continuation of a granted U.S. patent entitledDermal Patch for Collecting a Physiological Sample having patent Ser.No. 11,510,602 filed on Nov. 8, 2021 which is incorporated by referenceherein in its entirety.

TECHNICAL FIELD

The following relates to dermal patches and more particularly to dermalpatches for collection and/or analysis of a physiological sample.

BACKGROUND

Biomarkers are increasingly employed for diagnosis of various diseaseconditions as well as for assessing treatment protocols. Unfortunately,the invasive nature of drawing a blood sample from a subject can causediscomfort and may lead to less cooperation from the subject, especiallychildren, and hence render obtaining the blood sample difficult.

Some recently developed dermal patches allow for the detection of targetbiomarkers, but typically suffer from a number of shortcomings, such aslow sensitivity and/or specificity. Some dermal patches allow a user tocollect a physiological sample in order to send the collected sample toa laboratory for analysis.

There is still a need for dermal patches that can allow facilecollection of a physiological sample (e.g., a blood sample) in a varietyof environments for storage and/or for in-situ analysis.

SUMMARY

Aspects of the present disclosure address the above-referenced problemsand/or others.

In one aspect, a dermal patch for collecting, and optionally analyzing,a physiological sample includes a housing (herein also referred to as a“frame”) that includes a sample collection chamber, a sample fluidicchannel and a pin within a receptacle of the housing. The sample fluidicchannel is configured to direct a physiological sample drawn from asubject to the collection chamber. The pin is removably positionedwithin the receptacle and is configured to be moved (e.g., it can bepulled by a user) from an undeployed position to a deployed position.The pin is configured to seal the receptacle when in the undeployedposition and is further configured to facilitate generation of anegative pressure in the sample fluidic channel when the pin is movedfrom the undeployed to the deployed position. The physiological samplecan include, but is not limited to blood and interstitial fluid

In some embodiments, the housing also includes an opening that iscovered by a septum. When the dermal patch is attached to a subject'sskin, the septum may be punctured by a lancet thereby allowing access tothe subject's skin, which can be punctured by the lancet via passagethrough the punctured septum and the opening below the septum to allowdrawing a physiological sample for collection and/or analysis. In someembodiments, the septum is formed of a self-healing polymeric material(e.g., Polyisoprene and thermoplastic elastomers (“TPE”)), which cancreate a sealed surface after withdrawal of the lancet such that thephysiological sample (e.g., blood and/or interstitial fluid) will bedrawn into the collection chamber via passage in the space between thebottom of the septum and the skin, e.g., in a manner discussed in moredetail below.

In some embodiments, the dermal patch further includes a processingfluid reservoir (e.g., a processing fluid pouch), such as a fluid pack,that is coupled to the housing, e.g., disposed within the housing. Avariety of processing fluids may be stored within the processing fluidpouch. By way of example, and without limitation, the processing fluidmay be an anti-coagulant (e.g., heparin or a protease inhibitor), areagent, and/or a buffer. For example, a plurality of bufferformulations, such as lysing buffers, are known and can be incorporatedin various embodiments of a dermal patch according to the presentteachings.

In some embodiments, the dermal patch also includes a slider that isslidably coupled to the housing. The slider is moveable between anundeployed position and a deployed position. In the deployed position,the slider causes the release of the processing fluid from the fluidpouch. In some embodiments, the housing may also include a processingfluidic channel that directs the released processing fluid to thecollection chamber, e.g., to be mixed and interact with a collectedphysiological sample, e.g., blood.

In other embodiments, the dermal patch includes a detector (herein alsoreferred to as a sensor) that is in communication with the collectionchamber. The detector can generate one or more signals indicative of thepresence of a target analyte in a drawn physiological sample or aprocessed physiological sample. When the processing fluid and thephysiological sample enter the collection chamber, they mix and interactto form a processed physiological sample. In some embodiments, theinteraction of the drawn physiological sample and the processing fluidcan prepare the sample for storage and/or in-situ analysis.

The detector incorporated in a dermal patch according to the presentteachings can be used to detect a variety of analytes. Further, in someembodiments, the detector can be a calibrated detector that can not onlydetect, but also quantify, an analyte of interest, when present in thedrawn physiological sample. By way of example and without limitation,the target analyte may include a biomarker including, but not limitedto, troponin, brain natriuretic peptide (BnP), myelin basic protein(MBP), ubiquitin carboxyl-terminal hydrolase isoenzyme Ll (UCHL-1),neuron-specific enolase (NSE), glial fibrillary acidic protein (GFAP),S100-B, Cardiac troponin I protein (cTnl), Cardiac troponin T protein(cTnT), C-reactive protein (CRP), B-type natriuretic peptide (BNP),Myeloperoxidase, Creatine kinase MB, Myoglobin, Hemoglobin, or HbA1C. Insome embodiments, the target analyte may be a pathogen, e.g., abacterium or a virus. Further, a variety of detectors can be employed inthe practice of the present teachings. Some examples of suitabledetectors can include, without limitation, a lateral flow detector, anelectrochemical detector, or a graphene-based detector.

In some embodiments, the dermal patch also includes an absorbent element(hereinafter also referred to as absorbent pad) that is disposed in thecollection chamber and is configured to absorb at least a portion of thedrawn physiological sample. The absorbent element can be used to storethe collected physiological sample for analysis. For example, theabsorbent element may be removed from the patch and sent to a laboratoryfor analysis of the collected sample. By way of example and withoutlimitation, the absorbent element can be a filter paper matrix, (e.g., anitrocellulose strip), microfiber filters, gauze, non-woven sheets,polymers, etc. In other embodiments, the absorbent element may be leftin the dermal patch and the dermal patch may be sent to a lab forfurther analysis. At the lab, a technician may remove the absorbentelement form the dermal patch to analyze the physiological sample.

In some embodiments, the dermal patch also includes an adhesive layerfor attaching the dermal patch to the subject's skin.

In another aspect, a method for collecting a physiological sampleincludes applying a dermal patch to a subject's skin, puncturing thesubject's skin, drawing the physiological sample, releasing a processingfluid stored within the dermal patch, causing the drawn physiologicalsample and the released processing fluid to mix (e.g., by directing thedrawn physiological sample and the released processing fluid to acollection chamber of the dermal patch). In some embodiments, the sampleand the processing fluid mix and interact within the collection chamberto form a processed physiological sample and the method further includesdetecting a target analyte within the processed physiological samplewith a detector that is in communication with the collection chamber.

In some embodiments, the dermal patch can include multiple fluidreservoirs (e.g., multiple fluid pouches), for example, for storingdifferent processing fluids. The fluid reservoirs can be activated,e.g., concurrently or in any desirable sequence, to release theprocessing fluid contained therein for use, for example, in an assayperformed on the collected physiological sample. For example, theprocessing fluids can flow through one or more fluidic channels to mixwith the sample and/or be delivered to a detector in order to take partin the assay, e.g., through mixing and/or delivery to the detector(e.g., via deposition on a lateral flow assay (LFA) strip and/or othertypes of detector.

Further understanding of various aspects of the present teachings can beobtained by reference to the following detailed description inconjunction with the associated drawings, which are described brieflybelow.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects of the present disclosure may take form in various componentsand arrangements of components, and in various steps and arrangements ofsteps. The drawings are only for illustration purposes of preferredembodiments of the present disclosure and are not to be considered aslimiting.

Features of embodiments of the present disclosure will be more readilyunderstood from the following detailed description take in conjunctionwith the accompanying drawings in which:

FIG. 1 depicts a dermal patch in accordance with an exemplaryembodiment;

FIG. 2 is a cross sectional view of a dermal patch in accordance with anexemplary embodiment;

FIG. 3 is a cross sectional view of a pin that can be activated togenerate a negative pressure in one or more channels of a dermal patchto facilitate the drawing of a physiological sample in accordance withan exemplary embodiment;

FIG. 4 schematically depicts the pin of a dermal patch shown in FIG. 3being transitioned from an undeployed position to a deployed positionvia removal from a receptacle on the dermal patch housing the pin;

FIG. 5 is a cross sectional view of a slider of a dermal patch inaccordance with an exemplary embodiment;

FIG. 6 depicts a slider of a dermal patch in an undeployed position inaccordance with an exemplary embodiment;

FIG. 7 depicts a slider of a dermal patch in a deployed position inaccordance with an exemplary embodiment;

FIG. 8 diagrammatically illustrates a dermal patch in accordance with anexemplary embodiment;

FIG. 9 depicts diagrammatically a computer system that can be utilizedto analyze data generated by a detector incorporated in a dermal patchin accordance with an exemplary embodiment;

FIG. 10 depicts a dermal patch in accordance with an exemplaryembodiment;

FIG. 11 is a cross sectional view of a dermal patch in accordance withan exemplary embodiment;

FIG. 12 is a cross sectional view of a lancet in accordance with anexemplary embodiment;

FIG. 13 is a cross sectional view of a cover of a lancet in accordancewith an exemplary embodiment;

FIG. 14 is a cross sectional view of a needle platform of a lancet inaccordance with an exemplary embodiment;

FIG. 15 is a cross sectional view of a lancet connected to a dermalpatch, wherein the lancet is in an undeployed position lancet inaccordance with an exemplary embodiment;

FIG. 16 is a cross sectional view of a lancet connected to a dermalpatch, wherein the lancet is in a deployed position lancet in accordancewith an exemplary embodiment;

FIG. 17 depicts a pin of a dermal patch in accordance with an exemplaryembodiment;

FIG. 18 diagrammatically illustrates a dermal patch in accordance withan exemplary embodiment;

FIG. 19 diagrammatically illustrates a dermal patch with two collectionreservoirs in accordance with an exemplary embodiment;

FIG. 20 illustrates a method for detecting a target analyte in aphysiological sample in accordance with an exemplary embodiment;

FIG. 21 depicts a dermal patch with a quick response (“QR) code inaccordance with an exemplary embodiment;

FIG. 22 depicts a cloud computing environment in accordance with anexemplary embodiment;

FIG. 23 illustrates a method for automatically updating an electronicmedical record (“EMR”) in accordance with an exemplary embodiment;

FIG. 24 depicts a dermal patch with a QR code and a moveable cover in aclosed position in accordance with an exemplary embodiment;

FIG. 25 depicts a dermal patch with a QR code and a moveable cover in anopen position in accordance with an exemplary embodiment;

FIG. 26 depicts a bottom surface of a dermal patch with a skin sensor inaccordance with an exemplary embodiment;

FIG. 27 depicts a method for unlocking a dermal patch to draw aphysiological sample in accordance with an exemplary embodiment;

FIG. 28 depicts another method for unlocking a dermal patch to draw aphysiological sample in accordance with an exemplary embodiment;

FIG. 29 depicts a dermal patch in communication with two smartphones inaccordance with an exemplary embodiment;

FIG. 30 depicts another method for unlocking a dermal patch to draw aphysiological sample in accordance with an exemplary embodiment;

FIG. 31 depicts a metaverse network in accordance with an exemplaryembodiment;

FIG. 32 diagrammatically a computer system that can connect to ametaverse network in accordance with an exemplary embodiment; and

FIG. 33 depicts a metaverse in accordance with an exemplary embodiment.

DETAILED DESCRIPTION

The present disclosure generally relates to a dermal patch that may beutilized to collect and store a physiological sample (e.g., blood,interstitial fluid, etc.) and/or analyze a collected physiologicalsample, e.g., detect an analyte of interest in the collectedphysiological sample.

In some embodiments, a dermal patch that is used to collect aphysiological sample may include a processing fluid (e.g., reagent,buffer, anticoagulant, etc.). The processing fluid may be suitable forpreserving the physiological sample and/or preparing the sample foranalysis. Providing a dermal patch that includes a processing fluidcontained within a reservoir incorporated in the patch allows for thecollection and preservation of a physiological sample within the dermalpatch. Such a dermal patch can allow for facile collection and analysisof a physiological sample, e.g., in the field, at a medical facility, oreven at home.

In other embodiments, a dermal patch that is used to detect a targetanalyte (e.g., a biomarker) in a physiological sample includes aprocessing fluid and a detector that can detect a target analyte. Theprocessing fluid may be suitable for amplification of a target analyte(e.g., a primer). Providing a dermal patch that includes a processingfluid and a detector allows for the drawing of a physiological sampleand the detection of a target analyte within the dermal patch. Such adermal patch may allow a user of the dermal patch to detect an analytein a drawn physiological sample themselves at home.

Various terms are used herein in accordance with their ordinary meaningsin the art, unless indicated otherwise. The term “about,” as usedherein, denotes a deviation of at most 10% relative to a numericalvalue. The term “substantially,” as used herein, refers to a deviation,if any, of at most 10% from a complete state and/or condition. The term“lancet” is used herein to broadly refer to an element that can be usedto provide a passageway, or facilitate the production of a passageway,for collecting a physiological sample, such as a blood or aninterstitial fluid sample through a patient's skin, e.g., via puncturingthe subject's skin. The term “transparent,” as used herein, indicatesthat light can substantially pass through an object (e.g., a window) toallow visualization of a material disposed behind the object. Forexample, in some embodiments, a transparent object allows the passage ofat least 70%, or at least 80%, or at least 90%, of the visible lighttherethrough. The term “vacuum,” as used herein, refers to a pressureless than the atmospheric pressure, and more particularly to a pressurethat can facilitate the extraction of a physiological sample from asubject.

Referring now to FIGS. 1-8 a dermal patch 100 is shown in accordancewith an exemplary embodiment. The dermal patch 100 includes a topportion 200 and a bottom portion 300 that is coupled to the top portion200. In some embodiments, the top portion 200 is removably coupled tothe bottom portion 300. For example, in this embodiment, the top portion200 and the bottom portion 300 are formed as two separate componentsthat are removably coupled to one another. In another embodiment, thetop portion 200 and the bottom portion 300 form an integral unitarypatch. In some embodiments, the top portion 200 may be coupled to thebottom portion 300 via double sided adhesive, laser welding, pressfitting or a combination thereof.

The top portion 200 and the bottom portion 300 may be formed using avariety of suitable materials including, but not limited to, polymericmaterials, e.g., polyolefins, PET (Polyethylene Terephthalate),polyurethanes, polynorbornenes, polyethers, polyacrylates, polyamides(Polyether block amide also referred to as Pebax®), polysiloxanes,polyether amides, polyether esters, trans-polyisoprenes, polymethylmethacrylates (PMMA), cross-linked trans-polyoctylenes, cross-linkedpolyethylenes, cross-linked polyisoprenes, cross-linkedpolycyclooctenes, inorganic-organic hybrid polymers, co-polymer blendswith polyethylene and Kraton®, styrene-butadiene co-polymers,urethane-butadiene co-polymers, polycaprolactone or oligo caprolactoneco-polymers, polylactic acid (PLLA) or polylactide (PL/DLA) co-polymers,PLLA-polyglycolic acid (PGA) co-polymers, and photocross linkablepolymers. In some embodiments, some of the top portion 200 may be formedpoly(dimethylsiloxane) (PDMS) to allow visibility of components disposedwith the bottom portion 300.

The top portion 200 includes a top surface 202 and an opposed bottomsurface 204 and the bottom portion 300 includes a top surface 302 and anopposed bottom surface 304. When the top portion 200 is coupled to thebottom portion 300, the bottom surface 204 of the top portion 200contacts the top surface 302 of the bottom portion 300. The top portion200 and the bottom portion 300 define an aperture 102 that extendsthrough the top and the bottom portions 200/300. Stated another way, theaperture 102 extends between the top surface 202 of top portion 200 andthe bottom surface 304 of the bottom portion 300. As will be discussedin further detail below, the bottom portion 300 includes a plurality ofchannels. In order to seal these channels, a film (e.g., a polymericfilm) may be applied to the surface 302.

The dermal patch 100 also includes an adhesive layer 104 disposed on thebottom surface 304 of the bottom portion 300 and surrounds the aperture102 such that the adhesive layer 104 does not cover the aperture 102. Inuse the dermal patch 100 may be attached to a subject's skin via theadhesive layer 104. The adhesive layer 104 may be laminated to orheat/laser/adhesively bonded to the bottom surface 304. The dermal patch100 may be attached anywhere on the subject's skin capable of supportingthe dermal patch 100 (e.g., on a leg, arm, etc. of the subject). In someembodiments, a removable protective liner (not shown in the figures)covers the adhesive surface of the adhesive layer 104 and may be removedto expose the adhesive surface for attachment onto the subject's skin.

The dermal patch 100 further includes a septum 106, which extendslongitudinally along the top surface 302 of the bottom portion 300 so asto cover at least a portion of the aperture 102. The septum 106 may beformed of a polymeric material, such as polyisoprene, and may beconfigured such that it can be punctured via a lancet, as discussed inmore detail below. In some embodiments, the thickness of the septum 106can be in a range of about 0.015″ to about 0.040″ (e.g., 0.020″).

Once the dermal patch 100 is attached to a subject's skin, a user (e.g.,the subject wearing the dermal patch 100, a physician, a caretaker,etc.) may use a lancet 108 to puncture the septum 106 and further extendthe lancet through the aperture 102 to puncture the subject's skin,thereby providing access for drawing a physiological sample (e.g.,blood, interstitial fluid, etc.) from the subject. In some embodiments,the septum 106 may be self-sealing. In these embodiments, after thelancet 108 has been retracted from the septum 106, the septum 106 sealsand creates a sealed surface such that the drawn physiological samplecan flow within a space between a bottom surface of the septum 106 andthe skin of the subject (e.g., for collection in a collection chamber ofthe dermal patch 100).

The bottom portion 300 further includes a pin receptacle 306 that isshaped and dimensioned to receive a pin 400 and retain the pin 400 inplace via an interference fit. The base portion also includes a vacuumchannel 308 that is in fluid communication with the pin receptacle 306.As will be discussed in further detail herein, the distal portion of thepin 400 can include a plurality of grooves in which O-rings can bepositioned such that when the pin 400 is engaged within the pinreceptable 306 (e.g., when the pin 400 is in an undeployed position),the pin 400 forms an airtight seal within the pin receptacle 306. Aswill be discussed in further detail herein, the distal portion of thepin 400 can include a plurality of grooves in which sealing elements(O-rings in this embodiment) can be positioned such that when the pin400 is engaged within the pin receptable 306 (e.g., when the pin 400 isin an undeployed position), the pin 400 forms an airtight seal withinthe pin receptacle 306 to allow application of a positive or a negativepressure as needed, as described in more detail below.

More specifically, referring now to FIG. 3 the pin 400 includes acylindrical barrel 402, which includes an outer surface 404 that extendsbetween a proximal end 406 and a distal end 408 of the barrel 402. Theouter surface 404 defines a plurality of grooves 410 that extendcircumferentially about the barrel 402. The grooves 410 are shaped anddimensioned to retain elastomeric O-rings 412. When the barrel 402 ispositioned within the pin receptacle 306 (hereinafter referred to as “anundeployed position”), the elastomeric O-rings 412 contact the surfaceof the pin receptacle 306 to create an airtight seal between the barrel402 and the inner surface of the pin receptacle 306. While FIGS. 2 and 3depict the pin 400 as including the O-rings 412, in other embodiments,the pin 400 may include a single elastomeric piece, an overmold with asolid substrate and elastomeric O-rings or flaps that create the sealbetween the pin 400 and the surface of the pin receptacle 306.

The pin 400 further includes a handle 414 that is connected to thebarrel 402 and extends external to the pin receptacle 306 when thebarrel 402 is within the pin receptacle 306 and hence can be employed toremove the barrel 402 from the pin receptacle 306 and generate a vacuumfor drawing a physiological sample. In some embodiments, for exampleafter the pin has been removed and air has entered into the pinreceptacle 306, the pin can be reinserted into the pin receptacle 306thereby creating a positive pressure to further facilitate fluidic flow.

Stated another way, when the pin 400 is in the undeployed position, thehandle 414 is accessible to a user. In use, subsequent to puncturing theskin of a subject (e.g., by using the lancet 108 in a manner discussedabove) a user can pull the handle 414, e.g., using a draw string (notshown) attached to the handle 414, in the direction of arrow A (FIG. 4), to remove the barrel 402 from the pin receptacle 306 (hereinafterreferred to as a “deployed position”). Removing the barrel 402 from thepin receptacle 306 creates a vacuum within a vacuum channel 308, whichis in fluid communication with a physiological sample channel 310 (orsimply a “sample channel”). Thus, removing the pin barrel 402 from thepin receptacle 306 results in the generation of a vacuum within thesample channel 310, thereby facilitating the drawing of a physiologicalsample from the subject and directing the drawn physiological sampleinto a collection chamber 312. More specifically, the sample channel 310is in fluid communication with the aperture 102 and the collectionchamber 312, which is in turn in fluid communication with the vacuumchannel 308, and the sample channel 310. As such, the sample channel 310is in fluid communication with the vacuum channel 308 and hence candeliver the drawn physiological sample to the collection chamber 312upon creation of a vacuum within the vacuum channel 308.

In some embodiments, after the pin 400 has been removed from the pinreceptacle 306 to generate a vacuum for drawing a physiological sample,the pin 400 may be placed back into the pin receptacle 306 for storage.When placed back into the pin receptacle 306 the pin 400 displaces airwithin the pin receptacle 306 thereby creating positive pressure withinthe vacuum channel 308.

In this embodiment, the dermal patch 100 further includes a reservoir inthe form of a fluid pouch 500 formed of a frangible membrane thatprovides a sealed enclosure for storing a processing fluid forprocessing/stabilizing or otherwise treating a physiological sampledrawn from the subject. Further, the dermal patch 100 includes anactuator in the form of a slider 600 that can be actuated to release theprocessing fluid from the fluid pouch 500. While FIG. 2 depicts theprocessing fluid as being stored in the fluid pouch 500, in otherembodiments, the processing fluid may be stored in the dermal patch 100by other means. For example, the processing fluid may be directly storedin a reservoir molded into the bottom portion 300.

In particular, referring to FIG. 2 , the top portion 200 and the bottomportion 300 include channels 206 and 314 positioned in tandem and shapedand dimensioned to receive different portions of a slider 600 so as toretain the slider 600 in engagement with the rest of the dermal patch100. Stated another way, the two channels cooperatively provide areceptable for receiving the slider 600. FIG. 1 shows the slider 600 inan undeployed position. As discussed below, the slider 600 can be movedfrom the undeployed position to a deployed position to cause the releaseof a processing liquid from a reservoir provided in the dermal patch100.

More specifically, with reference to FIG. 5 , the slider 600 extendshorizontally between a proximal end 602 and a distal end 604 and extendsvertically between a top surface 606 and a bottom surface 608. Thebottom surface 608 includes a concave portion 610 that is in contactwith a processing fluid pouch 500. In this embodiment the curvature ofthe concave portion 610 substantially matches the convex curvature ofthe frangible membrane of the fluid pouch 500.

The slider 600 includes a channel 612 that divides the slider 600 into atop portion 614 and a bottom portion 616. The channel 612 can engagewith top raised ledges of the channels 314 and 206 provided in the topportion 200 and the bottom portion 300 of the dermal patch 100,respectively, such that the top portion 614 of the slider 600 isaccessible to a user while the bottom portion 616 is within the dermalpatch 100.

The slider 600 is moveable between an undeployed position (FIGS. 1 and 6) and a deployed position (FIG. 7 ) by moving the slider 600 in thedirection of arrow B (FIG. 6 ) such that the proximal end 602 of theslider 600 moves further into the channel 206 and the concave portion610 of the slider 600 presses against the frangible membrane of theprocessing fluid pouch 500 into a puncture element 316 provided in awell 318 that is positioned below the fluid pouch 500, thereby rupturingthe frangible membrane of the processing fluid pouch 500 and releasingthe processing fluid stored therein. In some embodiments, rather thanemploying a frangible membrane, a flexible membrane can be used thatdoes not rupture under applied pressure sufficient to cause the releaseof at least a portion of a liquid stored in the reservoir, e.g., via aone-way valve positioned in the bottom of the reservoir. The releasedprocessing fluid enters the well 318 and flows into a processing fluidchannel 320 provided in the base portion. The processing fluid channel320 provides a passageway for carrying the processing fluid to thecollection chamber 312.

A variety of processing liquids (e.g., reagents, buffers, anticoagulants(e.g., ethylenediaminetetraacetic acid (EDTA)), primers, etc.) can bestored within the sealed enclosure of the processing fluid pouch 500. Insome embodiments, the processing fluid is suitable for preserving aphysiological sample including, but not limited to, an anti-coagulant(e.g., heparin, a protease inhibitor, etc.). In other embodiments, theprocessing fluid is suitable for isothermal amplification of a targetanalyte, including but not limited to, a primer.

When the processing fluid and the physiological sample enter collectionchamber 312, the processing fluid mixes and interacts with thephysiological sample to form a processed physiological sample. In someembodiments, a physiological sample within the collection chamber 312can be captured using an absorbent element (e.g., a nitrocellulosestrip, a microfiber filter, gauze, a non-woven sheet, a polymer, etc.).In such embodiments, the absorbent element can be removed from thecollection chamber 312 and be utilized, for example, for analysis of thecollected physiological sample. In some embodiments, collectedphysiological sample can be subjected to genetic analysis (e.g., todetected a genetic marker indicative of susceptibility of a subject to aparticular disease).

In some embodiments, a detector 110 may be positioned within thecollection chamber 312 to receive at least a portion of the collectedphysiological sample and provide analysis of the sample, e.g., to detectone or more analytes of interest within the sample. Further, in someembodiments, a dermal patch according to the present teachings mayinclude two or more collection chambers 312 into each of which a portionof a drawn physiological sample is directed. In such embodiments, atleast one of the collection chambers 312 may include a detector 110 foranalysis of the drawn physiological sample and at least another one ofthe collection chambers 312 may be utilized for collection of a sampleto be analyzed external to the dermal patch. In some embodiments inwhich the dermal patch 100 includes a plurality of collection chambers312, the dermal patch 100 may include a plurality of detectors 110 eachin communication with at least one of the collection chambers 312. Forexample, the dermal patch 100 may include a first, a second, and a thirdcollection chamber 312. In this embodiment, the dermal patch may includea first detector 110 in communication with the first collection chamber312, a second detector 110 in communication with the second collectionchamber 312, and a third detector 110 in communication with the thirdcollection chamber 312.

In one embodiment, as depicted in FIG. 8 , the detector 110 ispositioned within the collection chamber 312. The detector 110 isconfigured to detect a target analyte within the processed physiologicalsample. In some embodiments, the detector 110 may detect a targetanalyte when the concentration of the target analyte within theprocessed sample is equal to or greater than a threshold (e.g., alimit-of detection (LOD)).

The detector 110 may be any detector capable of detecting a targetanalyte (e.g., a graphene-based detector, a chemical detector, a lateralflow detector, a DNA sequencing detector, an RNA sequencing detector,etc.). In some embodiments, the detector 110 may be capable ofgenerating a signal indicative of presence of the target analyte in thedrawn physiological sample. In some embodiments, the detector 110 may becalibrated to allow quantification of a target analyte, when present ina drawn physiological sample. Furthermore, the detector 110 may be apassive detector or an active detector and may provide chromatographicor “photo-visual,” or digital readouts (e.g., a colorimetric detector,an immunoassay detector including lateral flow detectors, isothermalamplification detection systems, etc.). In some embodiments in which acolorimetric detector is employed, at least a portion of the dermalpatch 100 may include a transparent window to allow the visualization ofthe detector 110.

In other embodiments, other suitable means for interrogating theprocessed physiological sample may be employed. By way of example, insome cases, the interrogation of a processed physiological sample may beachieved without the need for direct contact between a detector 110 andthe sample (e.g., optical techniques, such as fluorescent and/or Ramantechniques).

In some embodiments, the target analyte may be a pathogen (e.g., avirus, a bacterium, etc.). In these embodiments, the detector 110 may beconfigured to detect such a pathogen via the detection of a proteinand/or a genetic material thereof (e.g., segments of its DNA and/orRNA). In other embodiments, the detector 110 may be a lateral flowdetector that may be employed to detect a hormone. In other embodiments,the target analyte may be a biomarker (e.g., a biomarker that may beindicative of a disease condition (e.g., organ damage)). In theseembodiments, the biomarker may be indicative of a traumatic brain injury(TBI), including a mild TBI. Some examples of such biomarkers include,but are not limited to, myelin basic protein (MBP), ubiquitincarboxyl-terminal hydrolase isoenzyme L1 (UCHL-1), neuron-specificenolase (NSE), glial fibrillary acidic protein (GFAP), and S100-B.

In other embodiments, the detector 110 may be configured to detect otherbiomarkers, such as troponin and brain natriuretic peptide (BnP). Otherexamples include, but are not limited to, Cardiac troponin I protein(cTnl), Cardiac troponin T protein (cTnT), C-reactive protein (CRP),B-type natriuretic peptide (BNP), Myeloperoxidase, Creatine kinase MB,Myoglobin, Hemoglobin, and HbA1C.

In some embodiments, detector 110 may be configured to generate signalsindicative of levels of UCHL-1 and GFAP. These proteins are releasedfrom the brain into blood within 12 hours of head injury. The levels ofthese two proteins measured by the detector 110 according to the presentdisclosure after a mild TBI may help identify those patients that mayhave intracranial lesions.

In other embodiments, a biomarker detected by the detector may includebiomarkers associated with an immune response (i.e., CD4) and otherbiomarkers associated with specific diseases/conditions (i.e.,biomarkers associated with HIV, Malaria, Syphilis, pregnancy, etc.) Ingeneral, a dermal patch according to the present teachings can beconfigured, e.g., using a suitable detector, to detect any blood-basedbiomarker of interest in a blood sample drawn from a subject, such asthose disclosed herein.

In one embodiment, a target analyte may be detected by the detector 110when the detector 110 is a graphene-based detector that includes agraphene layer that is functionalized with a moiety (e.g., an antibody,an aptamer, an oligonucleotide, etc.) that exhibits specific binding tothat target analyte (e.g., a protein, a DNA segment) such that uponbinding of the target analyte to that moiety an electrical property ofthe underlying graphene layer changes, thus indicating the presence ofthe target analyte in the sample. By way of example, the detection of atarget analyte may be achieved by using a graphene-based detector and/oran electrochemical detector that is functionalized with a probe, such asan antibody and/or aptamer, which exhibits specific binding to thattarget analyte, though other sensing technologies may also be utilized.

In another embodiment, the detector 110 may be an electrochemicaldetector that functions in a faradaic or non-faradaic mode to detect atarget analyte of interest. For example, such an electrochemicaldetector may include a working electrode, a reference electrode, and acounter electrode. By way of example, in some embodiments, the referenceelectrode may be functionalized with a moiety that exhibits specificbinding to a target analyte such that upon binding of that targetanalyte, when present in the sample, to the moiety, a change in thecurrent through the circuit may be detected.

In some embodiments, at least one serum-separation element may beassociated with the detector 110 for receiving blood and separating aserum/plasma component of the blood for introduction into the detector110.

The serum-separating element may include a fibrous element that isconfigured to capture one or more cellular components of a drawn bloodsample so as to separate a plasma/serum component of the blood foranalysis. In some embodiments, the serum-separating element can be anitrocellulose strip. The use of such a fibrous element, and inparticular a nitrocellulose strip, may allow sufficient fractionation ofthe blood to enhance significantly the sensitivity/specificity ofdetection of analytes (e.g., biomarkers) in the separated serum,especially using a graphene-based detector. In other words, although theuse of a nitrocellulose strip in the dermal patch 100 according to someembodiments may not result in fractionation of the whole blood samplewith the same degree of separation quality that is achievable viatraditional fractionation methods, such as differential centrifugation;nonetheless, use of such a nitrocellulose strip in embodiments of thedermal patch 100 may significantly enhance the sensitivity/specificityfor the detection of a variety of analytes (e.g., biomarkers) using avariety of detectors, such as graphene-based detectors, relative to theuse of a whole blood sample for such detection. In some embodiments inwhich the detector 110 is a graphene-based detector, the nitrocellulosestrip may be positioned within the collection chamber 312 and coupled tothe detector 110 and the detector 110 may detect the target analyte viathe nitrocellulose strip.

Furthermore, in some embodiments, the serum-separation element mayinclude at least one fibrous membrane configured to capture at least aportion of one or more cellular components of the received blood,thereby separating a serum (or a plasma) component of the blood. In someembodiments, the separated plasma or the serum component may stillinclude some cellular elements. Even without having a level offractionation that is achieved via traditional methods, such asdifferential centrifugation, the separated serum component may beutilized to achieve an enhanced detection sensitivity/specificityrelative to using whole blood for detecting, and optionally quantifying,a variety of target analytes in a drawn blood sample. Some examples ofsuch target analytes may include, without limitation, a biomarker (e.g.,troponin, brain natriuretic peptide (BnP), or other biomarkers includingthose disclosed herein).

The separated serum component may include any of a plurality of redblood cells and/or a plurality of white blood cells and/or platelets.However, the concentration of such cellular components in the separatedserum component may be less than that in the whole blood by a factor ina range of about 2 to about 1000, though lower concentrations may alsobe achieved.

While the above describes the dermal patch 100 as including the detector110, in other embodiments, the detector 110 may be omitted. In theseembodiments, the collection chamber 312 may be configured to store theprocessed physiological sample so that the processed physiologicalsample may be analyzed at a later time as previously discussed herein.Furthermore, in such embodiments, an absorbent element (e.g., anitrocellulose strip, a microfiber filter, gauze, a non-woven sheet, apolymer, etc.) may be in communication with the collection chamber 312to collect at least a portion of the drawn physiological sample. Forexample, in one embodiment where the collection chamber 312 stores thedrawn physiological sample for later testing, a laboratory technicianmay remove the drawn physiological sample from the dermal patch 100 andemploy a detector or another device that is external to the dermal patch100 to analyze the drawn physiological sample (e.g., for further genetictesting).

In some embodiments, after the physiological sample is collected (e.g.,by contacting the drawn physiological sample to the absorbent element),the user of the dermal patch 100 may place the dermal patch 100 into asecure travel safe bag. This bag can be humidity controlled, ortemperature controlled or oxygen controlled, or UV/Light controlled orfor any purpose required to store the physiological sample.

As further depicted in FIG. 1 , the dermal patch 100 may house acomputer system (e.g., in the form of a programmed ASIC) 700 that is incommunication with the detector 110. The connection between the computersystem 700 and the detector 110 may be established via any of a wired orwireless protocol. In some embodiments, the computer system 700 and/orthe detector 110 can be supplied with power via an on-board power supply(e.g., a battery incorporated within the dermal patch 100).Alternatively, in some implementations, the computer system 700 and/orthe detector 110 can be provided with power via an external device(e.g., a wearable device). Such transfer of power from an externaldevice may be achieved using techniques known in the art, such asinductive coupling between two elements (e.g., two coils) provided inthe dermal patch 100 and the external device.

As will be discussed in further detail herein, the computer system 700receives one or more signals (e.g., detection signals) generated by thedetector 110 and determines whether the target analyte is present in thedrawn physiological sample at a quantity above the detector'slimit-of-detection (LOD). In some embodiments, the computer system 700may be configured to determine a quantitative level of the targetanalyte (e.g., the concentration of the target analyte in the collectedsample) based on the received signals, e.g., by employing one or morecalibration tables.

Referring now to FIG. 9 , the computer system 700 is shown in accordancewith an exemplary embodiment. As used herein a computer system (ordevice) is any system/device capable of receiving, processing, and/orsending data. Computer systems include, but are not limited to,microprocessor-based systems, personal computers, servers, hand-heldcomputing devices, tablets, smartphones, multiprocessor-based systems,mainframe computer systems, virtual reality (“VR”) headsets and thelike.

As shown in FIG. 9 , the computer system 700 includes one or moreprocessors or processing units 702, a system memory 704, and a bus 706that couples various components of the computer system 700 including thesystem memory 704 to the processor 702.

The system memory 704 includes a computer readable storage medium 708and volatile memory 710 (e.g., Random Access Memory, cache, etc.). Asused herein, a computer readable storage medium includes any media thatis capable of storing computer readable program instructions and isaccessible by a computer system. The computer readable storage medium708 includes non-volatile and non-transitory storage media (e.g., flashmemory, read only memory (ROM), hard disk drives, etc.). Computerreadable program instructions as described herein include programmodules (e.g., routines, programs, objects, components, logic, datastructures, etc.) that are executable by a processor. Furthermore,computer readable program instructions, when executed by a processor,can direct a computer system (e.g., the computer system 700) to functionin a particular manner such that a computer readable storage medium(e.g., the computer readable storage medium 708) comprises an article ofmanufacture. Specifically, when the computer readable programinstructions stored in the computer readable storage medium 708 areexecuted by the processor 702 they create means for determining apresence of a target analyte as a function of signals sent by thedetector 110 and optionally for quantifying a level of a target analyteas a function of signals sent by the detector 110 (e.g., the steps 814and 816 of the method 800).

The bus 706 may be one or more of any type of bus structure capable oftransmitting data between components of the computer system 700 (e.g., amemory bus, a memory controller, a peripheral bus, an acceleratedgraphics port, etc.).

The computer system 700 may further include a communication adapter 712which allows the computer system 700 to communicate with one or moreother computer systems/devices via one or communication protocols (e.g.,Wi-Fi, BTLE, etc.) and in some embodiments may allow the computer system700 to communicate with one or more other computer systems/devices overone or more networks (e.g., a local area network (LAN), a wide areanetwork (WAN), a public network (the Internet), etc.).

In some embodiments, the computer system 700 may be connected to one ormore external devices 714 and a display 716. As used herein, an externaldevice includes any device that allows a user to interact with acomputer system (e.g., mouse, keyboard, touch screen, etc.). An externaldevice 714 and the display 716 may be in communication with theprocessor 702 and the system memory 704 via an Input/Output (I/O)interface 718.

The display 716 may display a graphical user interface (GUI) that mayinclude a plurality of selectable icons and/or editable fields. A usermay use an external device 714 (e.g., a mouse) to select one or moreicons and/or edit one or more editable fields. Selecting an icon and/orediting a field may cause the processor 702 to execute computer readableprogram instructions stored in the computer readable storage medium 708.In one example, a user may use an external device 714 to interact withthe computer system 700 and cause the processor 702 to execute computerreadable program instructions relating to at least a portion of steps ofthe methods disclosed herein.

While FIG. 1 depicts the dermal patch 100 as including the computersystem 700, in some embodiments, the computer system 700 may be omitted.In these embodiments, the detector 110 may detect the target analytewithout any computer system 700 needed (e.g., a lateral flow assay).When the detector 110 is a lateral flow assay, the top portion 200 mayinclude a window that allows for visual inspection of the detector 110.Such visual inspection can be used to observe the result of the testprovided by the detector 110. Furthermore, in other embodiments thecomputer system 700 may be external from the dermal patch 100. In theseembodiments, the computer system 700 may be in wireless communicationwith the detector 110 as previously discussed herein.

Referring now to FIGS. 10-19 , another dermal patch 800 is depicted inaccordance with an exemplary embodiment. As will be discussed in furtherdetail herein, the dermal patch 800 is similar to the dermal patch 100,however in the dermal patch 800, the detector 110 and the fluid pouch500 has been omitted.

The dermal patch 800 includes a housing 802. The housing 802 may beformed using a variety of suitable materials including, but not limitedto, polymeric materials, e.g., polyolefins, PET (PolyethyleneTerephthalate), polyurethanes, polynorbornenes, polyethers,polyacrylates, polyamides (Polyether block amide also referred to asPebax®), polysiloxanes, polyether amides, polyether esters,trans-polyisoprenes, polymethyl methacrylates (PMMA), cross-linkedtrans-polyoctylenes, cross-linked polyethylenes, cross-linkedpolyisoprenes, cross-linked polycyclooctenes, inorganic-organic hybridpolymers, co-polymer blends with polyethylene and Kraton®,styrene-butadiene co-polymers, urethane-butadiene co-polymers,polycaprolactone or oligo caprolactone co-polymers, polylactic acid(PLLA) or polylactide (PL/DLA) co-polymers, PLLA-polyglycolic acid (PGA)co-polymers, and photocrosslinkable polymers. In some embodiments, someof the housing 802 may be formed poly(dimethylsiloxane) (PDMS) to allowvisibility of components disposed within the housing 802.

The housing 802 includes a top surface 804 and an opposed bottom surface806. The housing 800 defines an aperture 808 that extends through thehousing 802. Stated another way, the aperture 808 extends between thetop surface 804 and the bottom surface 806.

The dermal patch 800 also includes an adhesive layer 810 disposed on thebottom surface 806 thereof and surrounds the aperture 808 such that theadhesive layer 810 does not cover the aperture 808. In use, the dermalpatch 800 may be attached to a subject's skin as previously discussedherein with respect to the dermal patch 100. In some embodiments, aremoveable protective liner may cover the adhesive layer as previouslydiscussed herein.

The dermal patch 800 also includes a septum 812 which extendslongitudinally throughout the housing 802 such that the septum 812covers the aperture 808. The septum 812 may be formed of a polymericmaterial, such as polyisoprene, and may be configured such that it canbe punctured via a lancet, as previously discussed with respect to theseptum 106. In some embodiments, the thickness of the septum 812 can bein a range of about 0.015″ to about 0.040″.

In some embodiments, the septum 812 may be omitted. In theseembodiments, a lancet 900 (depicted in FIGS. 12-14 ) that engages withthe aperture 808 and seals the dermal patch 800 such that a vacuum maybe created within the dermal patch 800 may be employed to draw aphysiological sample as discussed in further detail below.

Referring now to FIGS. 12-14 , the lancet 900 is depicted in accordancewith an exemplary embodiment. The lancet 900 includes an outer wall 902,a concentric inner wall 904 and a cover 906. The inner wall 904 isretained within the outer wall 902 and the cover 906 is coupled to theouter wall 902 such that the cover 906 seals the lancet 900.

The outer wall 902 includes generally cylindrical wall 908. The wall 908includes an outer surface 908 a, an opposed inner surface 908 b, a topsurface 908 c, and a bottom surface 908 d. The outer surface 908 a andthe inner surface 908 b extend vertically between the top surface 908 cand the bottom surface 908 d and the top surface 908 c and the bottomsurface 908 d extend horizontally between the outer surface 908 a andthe inner surface 908 b. The wall 908 further includes a ledge 908 ethat extends circumferentially within the outer wall 902.

The inner surface 908 b defines an inner chamber 910 of the outer wall902. The wall 908 includes plurality of apertures 912 that extendthrough the wall 908. Stated another way, the apertures 912 extendbetween the outer surface 908 a and the inner surface 908 b of the wall908. The wall 908 also includes a groove 914 that extendscircumferentially around the wall 908. The groove 914 is shaped anddimensioned to accommodate an elastomeric O-ring 916 such that theelastomeric O-ring 916 is retained within the groove 918.

The cover 906 includes a top wall 918 with a top surface 918 a and abottom surface 918 b. When the cover 906 is coupled to the outer wall902, the bottom surface 918 b contacts the top surface 908 c of the wall908.

The cover 906 further includes an outer wall 920 that extends verticallyfrom the top wall 918. Specifically, the outer wall 920 extends from thebottom surface 918 b of the top wall 918. The outer wall 920 includes anouter surface 920 a, an opposed inner surface 920 b, and a bottomsurface 920 c. The outer surface 920 a and the inner surface 920 bextend vertically between the bottom surface 918 b of the top wall 918and the bottom surface 920 c. The bottom surface 920 c extendshorizontally between the outer surface 920 a and the inner surface 920b. Furthermore, when the cover 906 is coupled to the outer wall 902, theouter surface 920 a contacts the inner surface 908 b of the wall 908.

The cover 906 also includes an inner wall 922 that extends verticallyfrom the top wall 918. Specifically, the inner wall 922 extends from thebottom surface 918 b of the top wall 918. The inner wall 922 includes aninner surface 922 a, an opposed outer surface 922 b, and a bottomsurface 922 c. The outer surface 922 a and the inner surface 922 bextend vertically between the bottom surface 918 b of the top wall 918and the bottom surface 922 c. The bottom surface 922 c extendshorizontally between the outer surface 922 a and the inner surface 922b.

The inner wall 904 is retained within the inner chamber 910 of the outerwall 902 and includes a generally cylindrical wall 924 and a bottom wall926. The wall 924 extends vertically from the bottom wall 926 and bottomwall 926 extends horizontally between opposing sides of the wall 924.The wall 924 includes an outer surface 924 a, an opposed inner surface924 b and the bottom wall 926 includes a top surface 926 a and anopposed bottom surface 926 b. The wall 924 further includes a ledge 924c that contacts the ledge 908 e of the wall 908. The inner surface 924 bof the wall 924 defines an inner volume 928 of the inner wall 904. Thebottom wall 926 defines an aperture 930 that extends through the bottomwall 924. Stated another way, the aperture 930 extends between the topsurface 926 a and the bottom surface 926 b of the bottom wall 926.

The inner wall 904 further includes a plurality of latches 932 thatextend horizontally from and perpendicular to the wall 924.Specifically, the plurality of latches 932 extend horizontally from andperpendicular to the outer surface 924 a of the wall 924. When the innerwall 904 is coupled to the outer wall 902, the latches 932 extendthrough the apertures 912.

The lancet 900 further includes a needle platform 934 that is retainedwithin the inner volume 928 of the inner wall 904. The needle platformincludes a cylinder 936 with a top surface 936 a, a bottom surface 936 band an outer surface 936 c that extends vertically between the topsurface 936 a and the bottom surface 936 b. The needle platform 934 alsoincludes a lip 938 that extends horizontally beyond the outer surface9336 c of the cylinder 936. When the needle platform is within the innervolume 928 of the inner wall 904, the lip 938 contacts the inner surface924 b of the inner wall 904. The needle platform 934 is coupled to andsupports a needle 940. In some embodiments, the needle 940 is moldedinto the needle platform 934. The needle platform 934 further includes anotch 942, which extends vertically from and perpendicular to the topsurface 936 a of the cylinder 936.

The lancet 900 also includes a first biasing element (i.e., a spring)944 and a second biasing element (e.g., a spring) 946, whichcollectively allow causing the needle to puncture the subject's skin andthen retract. The first biasing element 944 extends circumferentiallyaround the inner wall 922 of the cover 906 and extends circumferentiallyaround the notch 942 of the needle platform 934. Furthermore, the firstbiasing element 944 contacts the bottom surface 918 b of the top wall918 of the cover 906 and contacts the top surface 936 a of the needleplatform 934. The second biasing element 946 extends circumferentiallyaround the needle 940 and contacts the bottom surface 936 b of theneedle platform 934 and the top surface 926 a of the inner wall 904.

The needle platform 934 is moveable between an undeployed position (FIG.15 ) and a deployed position (FIG. 16 ). In the undeployed position, thefirst biasing element 944 and the second biasing element 946 are,respectively, in a compressed and a stretched state so as to retain theneedle 940 within the lancet 900.

After the dermal patch 800 is adhered to the skin of the subject, thelancet 900 may be used to draw a physiological sample from the subject.First, a user may place the lancet vertically above the aperture 808such that the latches 932 of the lancet 900 contact the top surface 804of the housing 802. When a user of the dermal patch pushes the lancet900 further into the dermal patch 800, the latches 932 are displacedthereby releasing the needle platform 934 allowing the first biasingelement 944 to extend. When the first biasing element 944 extends, thefirst biasing element 944 moves the needle platform 934 from theundeployed position to the deployed position. In the deployed position,the needle 940 extends through the aperture 930 of the inner wall 904.This allows the needle 940 to puncture the septum 812 and draw aphysiological sample as previously discussed herein. Furthermore, whencompressed into the dermal patch 800, the elastomeric O-ring 916 formsan airtight seal within the dermal patch 800 thereby retaining the drawnphysiological sample between the septum and the skin of the subject.

While the above describes the lancet 900 as used in conjunction with thedermal patch 800, in other embodiments the dermal patch 800 may be usedwith the dermal patch 100. Furthermore, while the lancet 900 is depictedas separate from the dermal patch 800, in other embodiments, the lancet900 and the dermal patch may be formed as an integral unit (e.g., thelancet can be molded to the dermal patch 800. In this embodiment, thelancet 900 may be moved from the undeployed position to the deployedposition by rotating or pushing the lancet as previously discussed.

With reference to FIG. 11 , similar to the previous embodiment, thehousing 802 further includes a pin receptacle 814 that is shaped anddimensioned to receive a pin 816 and retain the pin 816 in place via aninterference fit. The housing 802 further includes a vacuum channel 818that is in fluid communication with the pin receptacle 814.

Referring now to FIG. 17 , the pin 816 includes a cylindrical barrel820, which includes an outer surface 822 that extends between a proximalend 824 and a distal end 826 of the barrel 820. The outer surface 822defines a plurality of grooves 828 that extend circumferentially aboutthe barrel 820. The grooves 828 are shaped and dimensioned to retainelastomeric O-rings 830. When the barrel 820 is positioned within thepin receptacle 814 (in the “undeployed position”), the elastomericO-rings 830 contact the surface of the pin receptacle 814 to create anairtight seal between the barrel 820 and the inner surface of the pinreceptacle 814.

The pin 816 further includes a handle 832 that is connected to thebarrel 820 and extends external to the pin receptacle 814 when thebarrel 820 is within the pin receptacle 814 and hence can be employed toremove the barrel 820 from the pin receptacle 814 and generate a vacuumfor drawing a physiological sample. In some embodiments, the dermalpatch and the pin can be configured such that the pin can be used toapply a positive pressure to create fluidic flow.

A user can pull the handle 832 as previously discussed herein to removepin 816 from the pin receptacle 814 to create a vacuum within the vacuumchannel 818 as previously discussed herein. The vacuum channel is incommunication with a physiological sample channel 834 which is incommunication with a collection chamber 836. Thus, removing the pinbarrel 820 from the pin receptacle 814 results in the generation of avacuum within the sample channel 834, thereby facilitating the drawingof a physiological sample from the subject and directing the drawnphysiological sample into a collection chamber 836 as previouslydiscussed herein.

The collection chamber 836 an absorbent element 838 as previouslydiscussed herein. The storage absorbent element 838 contacts the drawnphysiological sample and preserves the physiological sample for furthertesting (i.e., genetic testing) as previously discussed herein.

Referring now to FIG. 19 , in some embodiments, the dermal patch 800 mayinclude a plurality of collection chambers 836 each with an absorbentelement 838. In this embodiment the vacuum channel 818 and the samplechannel 834 each branch to both of the collection chambers 836. When thepin 816 is moved to the deployed position, the created vacuum draws thephysiological sample to both collection chambers 836 as previouslydiscussed herein.

Referring now to FIG. 10 a method 1000 for detecting a target analyte ina physiological sample is shown in accordance with an exemplaryembodiment. As previously discussed herein, the steps 1014 and 1016 ofthe method 1000 may be stored as computer readable program instructionsin a computer readable storage medium (e.g., the computer readablestorage medium 708). A processor that is configured according to anaspect of the present disclosure (hereinafter “a programmed processor”)executes the computer readable program instructions for the steps 1012and 1014 of method 1000. In one embodiment, the programmed processor isthe processor 702.

At 1002, the dermal patch 100 is applied to the skin of a subject viathe adhesive patch 104 as previously discussed herein.

At 1004, a user of the dermal patch 100 uses the lancet 108 to puncturethe skin of the subject to draw a physiological sample as previouslydiscussed herein.

At 1006, the user of the dermal patch 100 moves the pin 400 to thedeployed position to draw the physiological sample to the collectionchamber 312 as previously discussed herein.

At 1008, the user of the dermal patch 100 moves the slider 600 to thedeployed position to transfer the processing fluid stored in the fluidpouch 500 to the collection chamber 312 as previously discussed herein.

After the physiological sample and the processing fluid mix within thecollection chamber, at 1010, the detector 110 detects the target analytein the processed physiological sample and generates a signal indicativethereof as previously discussed herein.

At 1012, the programmed processor receives the signal(s) from thedetector 110 and determines the target analyte is present in thephysiological sample (or the processed physiological sample) when alevel of the target analyte exceeds a LOD and optionally quantifies alevel (e.g., concentration) of the target analyte as a function of thereceived signal(s) as previously discussed herein.

At 1014, the programmed processor outputs a notification indicative ofthe determined presence of the target analyte and/or the determinedlevel of the target analyte to the display 714. In response to receivingthe notification, the display 714 displays the notification.

Referring now to FIG. 21 , the dermal patch 100 is shown in accordancewith an exemplary embodiment. In this embodiment, a quick response(“QR”) code 112 is printed onto the top surface 202 of the top portion200 of the dermal patch. In this embodiment, a user may install anapplication stored as computer readable program instructions on acomputer system 114 (i.e., a smartphone, tablet, etc.) and employ acamera of the computer system 114 to take a photo of the QR code 112which is the saved in a memory of the computer system 114. Generally,the computer system 114 includes same or similar components as thecomputer system 700 (i.e., system memory, processor, display, etc.). Inthis embodiment, a processor of the computer system 114 may execute theprogram instructions associated with the application to retrieve thephotograph from the memory.

In some embodiments, the computer system 114 may be in communicationwith an electronic medical record (“EMR”) database 116 via a networkconnection. The EMR database 116 includes a plurality of EMRs 118 eachassociated with an individual subject. In these embodiments, theinstructions associated with the application further cause the processorof the computer system 114 to analyze the photograph to identify the QRcode 112 and associate the QR code 112 with an EMR 118 stored in the EMRdatabase 116. When the detector 110 includes a visible readout and thereadout is included in the photograph, the processor of the computersystem 114 may further analyze the received photo to evaluate thereadout and automatically determine the presence of a target analyteand/or a level of a target analyte based on the readout as previouslydiscussed herein.

Referring now to FIG. 22 , a cloud computing environment 1100 isdepicted in accordance with an exemplary embodiment. The cloud computingenvironment 1100 is connected to one or more user computer systems 1102and provides network access to shared computer resources (i.e., storage,memory, applications, virtual machines, etc.) to the one or more usercomputer systems 1102. As depicted in FIG. 22 , the cloud computingenvironment 1100 includes one or more interconnected nodes 1104. Eachnode 1104 may be a computer system or device with local processing andstorage capabilities. The nodes 1104 may be grouped and in communicationwith one another via one or more networks. This allows the cloudcomputing environment 1100 to offer software services to the one or moreuser computer systems 1102 and as such, a user computer system 1102 doesnot need to maintain resources locally.

In one embodiment, a node 1102 includes the computer system 700 or thecomputer system 114 and as such, includes the computer readable programinstructions for carrying out various steps of the methods discussedherein. In these embodiments, a user of a user computer system 1102 thatis connected the cloud computing environment 1100 may cause a node 1104to execute the computer readable program instructions to carry outvarious steps of the methods disclosed herein.

Referring now to FIG. 23 , a method 1200 for automatically updating anEMR is shown in accordance with an exemplary embodiment. Steps 1204-1210of the method 1200 may be stored as computer readable programinstructions in a computer readable storage medium (e.g., memory of thecomputer system 114, memory of a node 904, etc.). A programmed processor(e.g., a processor of the computer system 114, a processor of a node904, etc.) executes the computer readable program instructions for thesteps 1204-1210 of method 1200.

At 1202, the dermal patch 100 is applied to the skin of a subject, andis activated to draw a physiological sample from the subject (e.g., ablood sample or a sample of interstitial fluid) and the detector 110detects an analyte as previously discussed herein. Stated another way,at 1202 the steps 1002-1012 of the method 1000 are carried out.

At 1204, a user of the computer system 114 scans the QR code 112 with acamera of the computer system 114 as previously discussed herein and aprogrammed processor analyzes the QR code 112 and associates the QR code112 with an EMR 118.

At 1206, the programmed processor analyzes an image of the detectorread-out (e.g., an image of bands in a lateral flow strip detector) toevaluate the readout of the detector 110 and automatically determinewhether a target analyte is present in a physiological sample drawn fromthe subject, and optionally quantify the target analyte if the targetanalyte is detected in the sample as previously discussed herein.

At 1208, the programmed processor automatically updates the associatedEMR to include the determined presence of the target analyte and/or alevel of the target analyte. In some embodiments, at 1208, theprogrammed processor also updates the associated EMR to include thephotograph of the QR code and the detector 110.

At 1210, the programmed processor outputs a notification indicative ofthe determined presence of the target analyte and/or the determinedlevel of the target analyte to a display in communication with theprogrammed processor and/or outputs a notification indicative of thedetermined presence of the target analyte and/or the determined level ofthe target analyte to another device (i.e., a physician's smartphone).

Referring now to FIGS. 24 and 25 , in some embodiments the dermal patch100 may further include a moveable cover 120 and an electromechanicalactuator 122 configured to move the moveable cover 120 between a closedpositioned (FIG. 24 ) and an open position (FIG. 25 ). In the closedposition, the moveable cover 120 covers the aperture 102 and the septum106 and is generally impenetrable. As such, when the moveable cover 120is in the closed position and the dermal patch 100 has been adhered tothe subject, the cover 120 prevents a user from inserting the lancet 108through the septum 106 and the aperture 102 to draw a physiologicalsample from the subject. When in the open position the moveable cover120 is retracted within the dermal patch 100 such that the aperture 102and the septum 106 are exposed thereby allowing a user to draw aphysiological sample from the subject. While FIGS. 24 and 25 depict thedermal patch 100 as including the moveable cover 120, in otherembodiments, the dermal patch 100 may include other means that prevent auser of the dermal patch 100 from drawing the physiological sample fromthe subject.

The electromechanical actuator 122 is connected to and in communicationwith the computer system 700. As such, the electromechanical actuator122 is connected to and in communication with the processor 702. In someembodiments, the electromechanical actuator 122 is wirelessly connectedto the computer system 700 and in other embodiments the connectionbetween the electromechanical actuator 122 and the computer system 700is a wired connection. The electromechanical actuator 122 is configuredto move the cover 120 from the closed position to the open position inresponse to receiving a signal from the processor 702 to open the cover120. Stated another way, the electromechanical actuator 122 isconfigured to place the dermal patch 100 in a state ready to obtain andoptionally analyze a physiological sample in response to a signal fromthe processor 702.

Referring now to FIG. 26 , in some embodiments, the dermal patch 100further includes a skin sensor 124 located on the bottom surface 204 ofthe dermal patch 100. The skin sensor 124 is configured to determinewhen the dermal patch 100 is adhered to the skin of the subject. Statedanother way, the skin sensor 124 is configured to determine when thebottom surface 204 contacts skin of a subject. The skin sensor 124includes, but is not limited to optical sensors, infrared sensors, lightsensors, etc.

The skin sensor 124 is connected to and in communication with thecomputer system 700. As such, the skin sensor 124 is connected to and incommunication with the processor 702. In some embodiments, the skinsensor 124 is wirelessly connected to the computer system 700 and inother embodiments the connection between the skin sensor 124 and thecomputer system 700 is a wired connection. In response to determiningthe dermal patch is adhered to the skin of the subject, the skin sensor124 sends a signal to the processor 702 indicating that the dermal patch100 is adhered to the subject.

In some embodiments, in response to receiving the signal indicating thatthe dermal patch 100 is adhered to the subject, the processor 702 sendsa signal to open the cover 120 to the electromechanical actuator 116. Inresponse to receiving the signal to open the cover 120, theelectromechanical actuator 122 moves the cover 120 from the closedposition to the open position. Stated another way, the electromechanicalactuator 122 opens the cover 120 thereby allowing the user to draw aphysiological sample when the dermal patch 100 is adhered to skin of thesubject.

As previously discussed, a user may employ a camera of the computersystem 114 to scan the QR code 112. In some embodiments, before scanningthe QR code 112, the previously discussed installed application mayrequire a user to verify their identity (i.e., by entering a password,scanning a fingerprint, etc.). For example, the installed applicationmay require a user to enter a username and password that is associatedwith an EMR. In response to verifying the identity of the user, theapplication may unlock thereby allowing the user to scan the QR code112. Furthermore, after the application verifies the identity of theuser and in response to associating the QR code 112 with the correct EMRas previously discussed herein, the computer system 114 may send asignal indicating that the identity of the user has been verified to theprocessor 702. In some embodiments, in response to receiving the signalindicating that the identity of the user has been verified, theprocessor 702 sends a signal to open the cover 120 to theelectromechanical actuator 116. In response to receiving the signal toopen the cover 120, the electromechanical actuator 122 moves the cover120 from the closed position to the open position. Stated another way,the electromechanical actuator 122 opens the cover 120 thereby allowingthe user to draw a physiological sample when the identity of a user ofthe dermal patch 100 (i.e., the subject wearing that wears the dermalpatch 100) has been verified.

In some embodiments, before sending the signal to open the cover 120,the processor 702 may only send the signal in response to receiving bothsignal indicating that the identity of the user has been verified aspreviously discussed herein and a signal indicating that the dermalpatch 100 is adhered to the subject as previously discussed herein.

Referring now to FIG. 27 , a method 1300 for unlocking the dermal patch100 to draw a physiological sample is shown in accordance with anexemplary embodiment. Steps 1304 and 1306 of the method 1300 may bestored as computer readable program instructions in a computer readablestorage medium. A programmed processor executes the computer readableprogram instructions for the steps 1304 and 1306 of method 1300.

At 1302, the dermal patch 100 is applied to the skin of a subject viathe adhesive patch 104 as previously discussed herein.

At 1304, the skin sensor 124 determines if the dermal patch 100 isadhered to skin of the subject as previously discussed herein and inresponse to determining the dermal patch 100 is adhered to skin of thesubject, the skin sensor 124 sends a signal indicating the dermal patch100 is adhered to the subject to the processor 702.

At 1306, in response to receiving the signal indicating the dermal patch100 is adhered to the subject, the programmed processor sends a signalto the electromechanical actuator 116 to open the cover 120. In responseto receiving the signal to open the cover 120, the electromechanicalactuator 122 transitions the cover 120 from the closed position to theopen position as previously discussed herein.

Referring now to FIG. 28 , another method 1400 for unlocking the dermalpatch 100 to draw a physiological sample is shown in accordance with anexemplary embodiment. Steps 1404 and 1406 of the method 1400 may bestored as computer readable program instructions in a computer readablestorage medium. A programmed processor executes the computer readableprogram instructions for the steps 1404 and 1406 of method 1400.

At 1402, the dermal patch 100 is applied to the skin of a subject viathe adhesive patch 104 as previously discussed herein.

At 1404, a user scans the QR code 112 and the computer system 114verifies the identity of the user as previously discussed herein. Inresponse to verifying the identity of the user, the computer system 114sends a signal indicating that the identity of the user has beenverified to the processor 702 as previously discussed herein.

At 1406, in response to receiving the signal indicating that theidentity of the user has been verified, the programmed processor sends asignal to the electromechanical actuator 116 to open the cover 120. Inresponse to receiving the signal to open the cover 120, theelectromechanical actuator 122 transitions the cover 120 from the closedposition to the open position as previously discussed herein.

Referring now to FIG. 29 , a medical professional's computer system 126is depicted in accordance with an exemplary embodiment. While FIG. 29depicts the medical professional's computer system 126 as a smartphone,in other embodiments the medical professional's computer system 126 maybe another type of computer system (i.e., a tablet, laptop, etc.). Asdepicted in FIG. 29 , the medical professional's computer system 126 maybe connected to and in communication with one of or both of the computersystem 114 and the computer system 700 (i.e., when the medicalprofessional's computer system 126, the computer system 114, and/or thecomputer system 700 are connected to a same network).

As previously discussed herein, the processor 702 may receive a signalindicating that the dermal patch 100 is adhered to the subject's skinfrom the skin sensor 124 or a signal indicating that the identity of theuser has been verified. In response to receiving one or both of thesesignals, in the processor 702 may send a signal indicating that thedermal patch 100 is ready for operation to a processor of the medicalprofessional's computer system 126. In some embodiments, after verifyingthe identity of the user as previously discussed herein, a processor ofthe computer system 114 sends a signal indicating that the dermal patch100 is ready for operation to the medical professional's computer system126.

In response to receiving the signal indicating that the dermal patch 100is ready for operation, the processor of the medical professional'scomputer system 126 causes a display of the medical professional'scomputer system 126 to display a notification indicating the dermalpatch 100 is ready for operation and displays a GUI with an actuatableicon that when selected by the medical professional sends a signal toopen the cover 120 to the processor 702. In response to receiving thesignal to open the cover 120, the processor 702 causes the actuator 122to open the cover 120 as previously discussed herein.

Referring now to FIG. 30 , another method 1500 for unlocking the dermalpatch 100 to draw a physiological sample is shown in accordance with anexemplary embodiment. Steps 1504 and 1506 of the method 1500 may bestored as computer readable program instructions in a computer readablestorage medium. A programmed processor executes the computer readableprogram instructions for the steps 1504 and 1506 of method 1500.

At 1502, the dermal patch 100 is applied to the skin of a subject viathe adhesive patch 104 as previously discussed herein.

At 1504, a programmed processor sends a signal indicating the dermalpatch 100 is ready for operation to a medical professional's computersystem 126 in response to verifying an identity of a user and/or inresponse to determining the dermal patch 100 is adhered to skin of asubject as previously discussed herein. Furthermore, at 1504, inresponse to a medical professional selecting an icon displayed in a GUIof a display of the medical professional's computer system 126, themedical professional's computer system 126 sends a signal to open thecover 120 to the processor 702 as previously discussed herein.

At 1506, in response to receiving the signal to open the cover 120, theprogrammed processor 702 causes the actuator 122 to open the cover 120as previously discussed herein.

While the methods 1300, 1400, and 1500 include the processor 702 causingthe actuator 122 to move the cover 120 to the open position in responseto receiving one of a signal indicating the dermal patch 100 is adheredto the subject or a signal indicating that the identity of the user hasbeen verified or in response to receiving a signal to open the cover 120from the medical professional's computer system 126, in otherembodiments, the processor 702 sends the signal to open the cover 120 inresponse to receiving more than one of the previously recited signals.

Referring now to FIG. 31 , a metaverse network 1600 is shown inaccordance with an exemplary embodiment. The metaverse network 1600includes a plurality of user computer systems 1602, a metaverse server1604, and a network 1606. In some embodiments, the computer systems 1602may include one or more of the computer system 700, the computer system114 and the medical professional's computer system 126. While FIG. 13depicts the metaverse network 1600 as including three user computersystems 1602 and one metaverse sever 1604, in other embodiments themetaverse network 1600 may include more or less user computer systems1602 (e.g. 2, 5, 7, etc.) and more than one metaverse server 1604 (e.g.,2, 3, 6, etc.). The user computer systems 1602 are connected to andinterface with the metaverse server 1604 via a network (e.g., a localarea network (LAN), a wide area network (WAN), a public network (theInternet), etc.).

The metaverse server 1604 hosts a virtual reality environment and/or anaugmented reality environment (hereinafter “a metaverse”) with which theusers of a computer system 1602 may interact. In one embodiment, aspecified area of the metaverse is simulated by a single server instanceand the metaverse server 1604 may include a plurality of instances. Themetaverse server 1604 may also include a plurality of physics serversconfigured to simulate and manage interactions, collisions, etc. betweencharacters and objects within the metaverse. The metaverse server 1604may further include a plurality of storage servers configured to storedata relating to characters, media, objects, related computer readableprogram instructions, etc. for use in the metaverse.

The network 1606 may employ traditional internet protocols to allowcommunication between user computer systems 1602 and the metaverseserver 1604. In some embodiments, the user computer systems 1602 may bedirectly connected to the metaverse server 1604.

Referring now to FIG. 32 a user computer system 1602 is shown inaccordance with an exemplary embodiment. Generally, the user computersystem 1602 includes the same or similar components that operate in asame or similar manner as the components of the computer system 700(i.e., a processor 1608, system memory 1610, a bus 1612, a computerreadable storage medium 1614, volatile memory 1616, a communicationadapter 1618, one or more external devices 1620, a display 1622, and anI/O interface 1624). For the sake of brevity, these components areshown, but are not discussed in further detail herein.

The computer system 1602 also includes a metaverse client 1626 and anetwork client 1628. The metaverse client 1626 and the network client1628 include computer readable program instructions that may be executedby a processor 1608 of the user computer system 1602. While FIG. 23depicts the computer readable storage medium 1614 as including themetaverse client 1626 and the network client 1628, in other embodimentsthe metaverse client 1626 and the network client 1628 may be stored in adifferent location that is accessible to the processor 1608 (i.e., in astorage element of the cloud computing environment 900).

When executed, the metaverse client 1626 allows a user of a computersystem 1602 to connect to the metaverse server 1604 via the network 1606thereby allowing a user of the user computer system 1602 to interactwith the metaverse provided by the metaverse server 1604. The metaverseclient 1626 further allows a user of a user computer system 1602 tointeract with other users of other computer systems 1602 that are alsoconnected to the metaverse server 1604.

The network client 1628, when executed by the processor 1608, facilitiesconnection between the user computer system 1602 and the metaverseserver 1604 (i.e., by verifying credentials provided by the user). Forexample, when executed and a user of a computer system 1602 requests tolog onto the metaverse server 1604, the network client 1628 maintains astable connection between the user computer system 1602 and themetaverse server 1604 and handles commands input by a user of a computersystem 1602 and handles communications from the metaverse server 1604.

When a user of the user computer system 1602 is logged into themetaverse server 1604, the display 1622 conveys a visual representationof a metaverse provided by the metaverse server 1604. In someembodiments wherein a computer system 1602 is a VR headset and the VRheadset includes the display 1622, the metaverse server 1602 provides athree-dimensional (“3D”) environment to the VR headset thereby creatinga lifelike environment for the user.

In one embodiment, wherein the computer systems 700 and 114 are usercomputer systems 1602 (and therefore include the metaverse client 1626and the network client 1628), a user of the dermal patch may log intothe metaverse server 1604 by verifying their identity as previouslydiscussed herein. In response to verifying the identity of a user, thecomputer system 700 sends a signal indicating the user identity has beenverified to the metaverse server 114 and thereby logging the computersystems 700 and 114 into the metaverse.

When a user computer system 1602 logs into the metaverse server 1604,the metaverse server 1604 may generate a subject avatar 1630corresponding to a user of the dermal patch 100. In some embodiments,the metaverse server 1604 generates a generic subject avatar 1630 thatcorresponds to the user and in other embodiments, the subject avatar1630 has been previously generated by the metaverse based on userinputs. When the subject avatar 1630 is based on user inputs, the avatarmay look similar to a subject using the dermal patch 100.

With reference to FIG. 24 , The metaverse server 1604 also generates avirtual reality environment (or a “metaverse”) 1632. In someembodiments, the metaverse 1632 looks like a physician's examinationroom (i.e., including chairs, examination table, sink, etc.) and may bebased on user inputs to create a personalized metaverse 1632. After thesubject avatar 1630 is generated, the metaverse server 1604 populatesthe subject avatar 1630 into the metaverse 1632.

Furthermore when the computer system 700 and/or the computer system 114is a user computer system 1602 and is logged into the metaverse server1604, in response to the skin sensor 124 determining the dermal patch100 is contacting skin of the subject and sending a signal to thecomputer system 700 or the computer system 114 indicating the dermalpatch 100 is adhered to the subject as previously discussed herein, thecomputer system 700 or the computer system 114 may send a correspondingsignal to the metaverse server 1604. In response to receiving the signalindicating the dermal patch 100 is adhered to skin of the subject, themetaverse server 1604 generates a dermal patch avatar 1634 on thesubject avatar 1630. While the dermal patch avatar 1634 is depicted onan arm of the subject avatar 1630, in other embodiments, the dermalpatch avatar 1634 may be depicted as attached to different parts of thesubject avatar 1630 (i.e., on a leg of the subject avatar).

The dermal patch avatar 1634 includes an actuatable button 1636. When auser within the metaverse selects the actuatable button 1636, themetaverse server 1604 sends a signal to the processor 702 of the dermalpatch 100 to open the cover 120. In response to receiving the signal toopen the cover 120 from the metaverse server 1604, the processor 702causes the electromechanical actuator to open the cover 120 aspreviously discussed herein. Stated another way, a user in the metaverse1632 may place the dermal patch 100 in a ready position (i.e., byopening the cover 120) by pushing a button 1636 of a virtual dermalpatch 1634.

In some embodiments, the actuatable button 1636 may only be actuated bya user of a computer system 1602 with specific login credentials (i.e.,a medical professional). Stated another way, only a user with medicalprofessional credentials may cause the dermal patch 100 to enter a readyposition by actuating the actuatable button 1636.

In some embodiments, wherein a user computer system 1402 includes a VRheadset that is connected to the metaverse server 1604, a user may viewthe metaverse 1632 via a display of the VR headset. Furthermore, whenthe metaverse 1632 includes the subject avatar 1630 with the dermalpatch avatar 1634, the VR headset may track the hands of the user in theVR headset to determine when the user “pushes” (and therefore selects)the actuatable button 1636. In response to determining the user pushedthe actuatable button 1636, the VR headset (the user computer system1402) sends a signal to the metaverse server 1604 indicating a user hasselected the actuatable button 1636. In response to receiving thissignal, the metaverse server 1636 causes the dermal patch 100 to beplaced into a ready position.

In some embodiments, wherein a medical professional logs into themetaverse server 1604 via their login credentials, the metaverse servermay populate a corresponding avatar (e.g., a medical professionalavatar) into the metaverse 1632. In these embodiments, when the medicalprofessional selects the actuatable button 1636 the metaverse serverdepicts the medical professional's avatar as interacting with the dermalpatch avatar 1634.

While the above describes the dermal patch 100 as being capable ofconnecting with the metaverse server 1604, in other embodiments, thedermal patch 800 may include a moveable cover and a computer system thatallows the dermal patch 800 to connect to the metaverse as discussedherein. In this embodiment, the dermal patch 800 may be placed in aready position by a user selecting an actuatable button in the metaverseas previously discussed herein.

While the invention has been illustrated and described in detail in thedrawings and foregoing description, such illustration and descriptionare to be considered illustrative or exemplary and not restrictive;embodiments of the present disclosure are not limited to the disclosedembodiments. Other variations to the disclosed embodiments can beunderstood and effected by those skilled in the art in practicingembodiments of the present disclosure, from a study of the drawings, thedisclosure, and the appended claims.

In the claims, the word “comprising” does not exclude other elements orsteps, and the indefinite article “a” or “an” does not exclude aplurality. A single processor or other processing unit may fulfill thefunctions of several items recited in the claims. The mere fact thatcertain measures are recited in mutually different dependent claims doesnot indicate that a combination of these measured cannot be used toadvantage. Any reference signs in the claims should not be construed aslimiting the scope.

What is claimed is:
 1. A system comprising: a dermal patch comprising ahousing configured to attach to a subject's skin, wherein the housingincludes an opening to provide access to the subject's skin when thedermal patch is attached to the subject's skin, and a lancet configuredto engage with the opening, wherein the lancet includes a needle movablefrom an undeployed position to a deployed position, wherein in thedeployed position, the needle is capable of puncturing the skin to drawa physiological sample.
 2. The system of claim 1, wherein the lancet isconfigured to retain the needle within the lancet when the needle is inthe undeployed position.
 3. The system of claim 2, wherein the lancetincludes a first spring and a second spring.
 4. The system of claim 3,wherein when the needle is in the undeployed position the first springis in a compressed state and the second spring is in an extended state.5. The system of claim 3, wherein when the needle is in the deployedposition the first spring is in an extended state and the second springis in a compressed state.
 6. The system of claim 1, wherein the lancetfurther includes a needle platform that supports the needle.
 7. Thesystem of claim 1, wherein the housing further includes: a chamber, andan absorbent element disposed within the chamber, wherein the absorbentelement is configured to store the drawn physiological sample.
 8. Thesystem of claim 1, further comprising: a fluid pouch coupled to thehousing, wherein the fluid pouch is configured to store a processingfluid.
 9. The system of claim 8, wherein the fluid pouch is formed of afrangible membrane.
 10. The system of claim 9, further comprising: aslider coupled to the housing, wherein the housing further includes apuncture element, wherein the slider is configured to compress the fluidpouch into the puncture element to rupture the fluid pouch.
 11. Thesystem of claim 1, further comprising: a moveable pin disposed withinthe housing, wherein the pin is configured to generate a vacuum withinthe housing when moved, and wherein the vacuum generated by the pin isproportional to the movement of the pin.
 12. The dermal patch system ofclaim 11, wherein the housing further includes: a receptacle, whereinthe pin is disposed within the receptacle, and wherein the pin isconfigured to seal the receptacle.
 13. The system of claim 13, whereinthe housing further includes: a chamber configured to receive the drawnphysiological sample, and a channel in open communication with thechamber and the receptacle, wherein the pin is configured to generatethe vacuum within the channel to draw the drawn physiological sample tothe chamber.
 14. The system of claim 1, wherein the physiological sampleincludes blood or interstitial fluid.
 15. The system of claim 1, whereinhousing further includes: an adhesive film disposed on a bottom surfaceof the housing, wherein the adhesive film is configured to attach thehousing to the skin of the subject.
 16. A dermal patch comprising: ahousing configured to attach to the skin of a subject, wherein thehousing includes: a chamber, a receptacle, a pin disposed within thereceptacle, and a channel in open communication with the chamber and thereceptacle, wherein the pin is configured to move within the receptacleto generate a vacuum within the channel and the chamber, and wherein thevacuum generated by the pin is proportional to the movement of the pin.17. The dermal patch of claim 16, further comprising: an absorbentelement disposed within the chamber.
 18. The dermal patch of claim 16,further comprising: a detector disposed within the chamber, wherein thedetector is configured to detect the presence of a target analyte in aphysiological sample.
 19. A method for collecting a physiological samplecomprising: attaching a dermal patch to the skin of a subject,puncturing the skin of the subject to draw a physiological sample, anddrawing the physiological sample and a processing fluid stored withinthe dermal patch to a collection chamber of the dermal patch.
 20. Themethod of claim 19, wherein the physiological sample and the processingfluid mix within the collection chamber to form a processedphysiological sample and the method further includes: detecting a targetanalyte within the processed physiological sample with a detector thatis in communication with the collection chamber.